Federal Court Declares Genetically Engineered Salmon Unlawful

What did the court say?

• In approving genetically engineered salmon, the Food and Drug Administration violated the Endangered Species Act and National Environmental Policy Act.
• FDA’s unilateral decision that genetically engineered salmon could have no possible effect on highly-endangered, wild Atlantic salmon was wrong.
• Read the court ruling issued on Nov. 5, 2020.

What happens next?

• FDA is ordered to go back to the drawing board.
• FDA must now thoroughly analyze the environmental consequences of an escape of genetically engineered salmon into the wild.

How was Earthjustice involved?

• Earthjustice and the Center for Food Safety brought the lawsuit challenging the FDA for approving the first-ever commercial genetically engineered animal.
• We represented a client coalition of environmental, consumer, commercial and recreational fishing organizations, and the Quinault Indian Nation.

Why is this a big deal?

The FDA became the first government agency in the world to approve a genetically engineered food animal for sale and human consumption. Created by the company AquaBounty, the laboratory construct known as “AquaAdvantage Salmon” was approved by the FDA in 2015.

The FDA’s action would likely serve as a precedent for the assessment of all future GE food animals and for review of their impacts on the environment.

What’s wrong with GE salmon?

Instead of fixing the environmental problems we have created or investing in the protection and recovery of our existing wild salmon resources, investing in genetically engineered salmon brings a host of new threats to imperiled wild salmon—further undermining the sustainability of our food supply.

This man-made animal highlights the ways we have devastated many of our wild fish populations and our continuing failure to recover this once-abundant natural food source.

Are GE salmon a threat to wild salmon?

Yes. The risks are very real and would be irreversible.

If GE salmon escape into the environment, they would threaten native species via predation or competition for limited food and space, transgenic contamination, and an increase in exotic diseases and parasites.

Once engineered organisms are let loose into the environment, it is impossible to recall or eliminate them. Unlike chemical pollution, GE contamination is a living pollution that can propagate itself over space and time via gene flow.

How was the new food animal engineered?

By combining DNA from three animals: Atlantic salmon (Salmo salar), deep water ocean eelpout (Macrozoarces americanus) and Pacific Chinook salmon (Oncorhynchus tshawytscha).

(Pacific Chinook salmon are a different species from Atlantic salmon.)

Why was this done?

To manufacture an animal that grows unnaturally fast. The genetic engineering causes overproduction of an insulin-like growth factor hormone. The new animal purportedly grows to commercial size in half the time of conventional Atlantic salmon.

Are GE salmon in stores now?

No. Though the company has not announced its detailed plans for distribution and sale, it appears possible that these fish could arrive in restaurants and cafeterias soon.

Where will GE salmon be created?

Genetically engineered eggs will be produced on Prince Edward Island, Canada. Right now, they are sent to Indiana, where they are grown to market-size and processed into fillets.

Aren’t GE salmon manufactured to be sterile?

GE salmon eggs are treated to be sterile, but these methods are only 95–97% effective. With hundreds of thousands of eggs in production, this inevitable failure rate results in thousands of fertile fish.

The adult salmon that have been engineered to fertilize the eggs (broodstock) are not sterile and could mate with native salmon in the wild.

Is it likely that GE salmon will escape into the wild?

While FDA assumes this won’t happen, numerous independent scientists—and many within the federal fish and wildlife agencies—highlighted that FDA’s analysis of this risk was woefully incomplete.

Farmed salmon already routinely escape into the wild, and already exceed wild salmon in some river systems. Especially given AquaBounty plans to expand its sales to farmed salmon facilities in other countries—including the U.S.—it is simply unrealistic to expect that GE salmon will not escape into the wild.

What’s the current state of wild salmon?

Not good.

On the east coast, of the New England rivers in which Atlantic salmon runs were historically found, only 16% currently support salmon. The remaining populations are so low that all U.S. Atlantic salmon are listed as endangered.

The situation is no better on the west coast. The National Marine Fisheries Service has listed the following Pacific salmon and steelhead Evolutionarily Significant Units and Distinct Population Segments as threatened or endangered:

California coastal Chinook salmon, Central Valley spring-run Chinook salmon, Lower Columbia River Chinook salmon, Puget Sound Chinook salmon, Sacramento River winter-run Chinook salmon, Snake River fall-run Chinook salmon, Snake River spring/summer-run Chinook salmon, Upper Columbia River spring-run Chinook salmon, Upper Willamette River Chinook salmon, Columbia River chum salmon, Hood Canal summer run chum salmon, Central California Coast coho salmon, Southern Oregon and Northern Coastal California coho salmon, Lower Columbia River coho, Oregon Coast coho salmon, Snake River sockeye salmon, Central California Coast steelhead, California Central Valley steelhead, Lower Columbia River steelhead, Middle Columbia River steelhead, Northern California steelhead, Snake River Basin steelhead, South-Central California Coast steelhead, Southern California steelhead, Upper Columbia River steelhead, and Upper Willamette River steelhead.

The scattered remaining healthy Pacific salmon fisheries—such as those in Bristol Bay, Alaska—constitute some of the best, and most valuable, remaining wild fisheries on earth.

What’s wrong with the way GE salmon was approved for market?

FDA claims jurisdiction to regulate these animals, but does not have the expertise. The agency exists to ensure that the food and drugs we consume are safe for humans. It does not typically evaluate the environmental impacts of new types of engineered foods in the ecosystem. The two agencies with actual biological expertise in fisheries and ocean ecosystems, National Marine Fisheries Service and U.S. Fish and Wildlife Service, were not given the chance to formally review FDA’s approval.

Who has criticized the approval of GE salmon?

The world’s preeminent experts on GE fish, Dr. Anne Kapuscinski and Dr. Frederik Sundström, as well as biologists at the National Marine Fisheries Service and Fish and Wildlife Service. They heavily criticized the FDA decision for significant deficiencies in the science (and scientific approach) the agency took to evaluate environmental risks.

1.8 million members of the public submitted comments in opposition to the approval, due to FDA’s failure to analyze and prevent risks to wild salmon and the environment.

A coalition of eleven environmental, consumer, and commercial and recreational fishing organizations, jointly represented by legal counsel from Center for Food Safety and Earthjustice, sued the FDA over approval on March 30, 2016.

What’s happening now?

A federal court ruled on Nov. 5, 2020, on our legal challenge to the FDA’s decision to approve GE salmon, finding that FDA ignored the serious environmental consequences of approving genetically engineered salmon and the full extent of plans to grow and commercialize the salmon in the U.S. and around the world, violating the National Environmental Policy Act.

The court also ruled that FDA’s unilateral decision that genetically engineered salmon could have no possible effect on highly-endangered, wild Atlantic salmon was wrong, in violation of the Endangered Species Act.

The court also rejected FDA’s argument that it lacked authority to ensure the environmental safety of GE animals, including the GE salmon. To find otherwise, the court reasoned, would lead to “absurd possibilities,” like approval of GE animals that could cause serious harm to other life.

The court ordered FDA to go back to the drawing board and FDA must now thoroughly analyze the environmental consequences of an escape of genetically engineered salmon into the wild.

A new federal labeling law now preempts stricter state laws to require GE salmon to be clearly labeled for consumers.

What can I do now?

Sign up for important updates from Earthjustice on this legal challenge and on opportunities to get involved. And, support the earth’s legal team with a tax-deductible donation.

Resources on this legal case